AbstractBackground and objectiveBronchoscopic lung volume reduction coil (LVR‐coil) treatment has been shown to be safe and clinically effective in patients with severe emphysema in the short term; however, long‐term safety and effectiveness has not been evaluated. The aim of this study was to investigate the long‐term safety and effectiveness of LVR‐coil treatment in patients with severe emphysema.
MethodsThirty‐eight patients with severe emphysema (median age is 59 years, forced expiratory volume in 1 s is 27% predicted) who were treated in LVR‐coil clinical trials were invited for a voluntary annual visit. Safety was evaluated by chest X‐ray and recording of adverse events and by efficacy by pulmonary function testing, 6‐min walk distance (6MWD) and questionnaires.
ResultsThirty‐five patients visited the hospital 1 year, 27 patients 2 years and 22 patients 3 years following coil placement. No coil migrations were observed on X‐rays. At 1‐year follow‐up, all clinical outcomes significantly improved compared with baseline. At 2 years, residual volume % pred, modified Medical Research Council (mMRC) and the SGRQ score were still significantly improved. At 3 years, a significant improvement in mMRC score remained, with 40% of the patients reaching the 6MWD minimal important difference, and 59% for the St George's Respiratory Questionnaire (SGRQ) minimal important difference.
ConclusionsFollow‐up of the patients treated with LVR‐coils in our pilot studies showed that the coil treatment is safe with no late pneumothoraces, coil migrations or unexpected adverse events. Clinical benefit gradually declines over time; at 3 years post‐treatment, around 50% of the patients maintained improvement in 6MWD, SGRQ and mMRC.
Clinical trial registrationNCT01220908 and NCT01328899 registered at ClinicalTrials.gov.